An observational study in Esophageal Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-26.
Sponsored by Abramson Cancer Center at Penn Medicine · Observational
The purpose of this research study will be to determine the sensitivity and specificity of dwMRI metrics to assess tumor response following neoadjuvant chemoradiation in esophageal cancer. This pilot study will generate the preliminary data needed for the design of a statistically-justified trial that would investigate dwMRI as an integral biomarker to stratify patients for escalated therapy to improve outcomes. We hope to develop dwMRI as a predictive clinical tool for a personalized treatment model that can identify patients who may be candidates for organ-preservation or treatment intensification to improve outcomes in esophageal cancer.
1,631 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.
This study's enrollment of 11 is below the median of 200 across 346 observational studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 457 studies on the registry; 84 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.
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Patients with a histologic diagnosis of adenocarcinoma of the esophagus located distal to the carina
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Exclusion Criteria:
Patients will have their chemotherapy coordinated through the Medical Oncology department at the University of Pennsylvania, and will be followed by Medical Oncology at Penn during chemoradiation. As part of the standard of care for locally advanced esophageal cancer, neoadjuvant concurrent chemotherapy will likely consist of weekly carboplatin and paclitaxel, beginning within 1 day of starting radiation therapy and continuing until the completion of radiation treatment. Alternative chemotherapy regimens, dose adjustments or delays in administration will be determined at the discretion of the treating medical oncologist and recorded in the patient's chart.
Patients will have their radiation therapy coordinated and performed through the Radiation Oncology Department at the University of Pennsylvania. The development and delivery of the patient's radiation treatment plan will be at the discretion of the treating radiation oncologist, and details will be recorded in the patient's chart.
Patients will have their surgery coordinated and performed through Thoracic Surgery department at the University of Pennsylvania. Patients will undergo esophagectomy 4-8 weeks after the completion of neoadjuvant chemoradiation as part of the standard of care.
A total of 40 paired MRI examinations from eligible participants will be collected in the Department of Radiology at the Hospital of the University of Pennsylvania. Participants will undergo two 1.5T MRI studies performed at two time points: (1) within 28 days prior to starting neoadjuvant chemoradiation, and (2) between radiation fraction 8-13 during treatment. The quantitative imaging studies for the trial (DWI) will be performed with and without respiratory gating using a navigator, with B values of 0, 100, 600 and 800 s/mm2.
The procedure of blood collection for each patient will be as follows: the total amount being drawn each time will be approximately 30 cc. Approximately 25 ml of blood will be collected into heparinized tubes, and immediately placed on ice in a prepared plastic bag and transported to the laboratory for processing within 1 hour. If necessary, we may need up to 2 hours in order to begin processing the blood; in the event that longer than this time period has transpired, the sample will be deemed inadequate for processing purposes. The first blood draw will be obtained prior to the first fraction of radiation treatment and will be coordinated to occur at the time of pre-treatment MRI. Thereafter, the second sample will be obtained during chemoradiation therapy, between fraction 8-13 and the blood draw will be coordinated with the on-treatment MRI scan.
Number of MRIs
Time frame: 2 years
Ran from Apr 2017 to primary completion in Aug 2019, 28 months.
Of 125 non-industry observational studies under Esophageal Neoplasms, half reached primary completion within 112 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 318. This study's 28 months is below that.
Counting every sponsor, half of 139 studies reached it within 99 months; a quarter within 41 and three quarters within 318.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Abramson Cancer Center at Penn Medicine →